ArthropathyNCT06440863
Postoperative BMI Changes and Functional Outcomes in Knee and Hip Arthroplasty
A study testing Total Knee Arthroplasty and Total Hip arthroplasty in people with Arthropathy and Obesity, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
PURPOSE Obesity poses challenges to preoperative mobility and functional recovery for arthroplasty patients, yet postoperative weight loss remains elusive. This study aims to investigate postoperative weight changes and their impact on functional scores following knee and hip arthroplasty, exploring factors… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Arthropathy, Obesity
- What is being tested?
- Total Knee Arthroplasty and Total Hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent primary TKA and THA with a 2-year follow-up were included
Who cannot join
- Patients who underwent bariatric surgery before or after the surgery
- Incomplete 2-year follow-up
- Whom BMI or Oxford scores could not be accessed
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, Fatih, 34098
About this study
Official title: The Effect of Changes in Body Mass Index After Total Knee and Hip Arthroplasty on Patient Functional Scores
PURPOSE Obesity poses challenges to preoperative mobility and functional recovery for arthroplasty patients, yet postoperative weight loss remains elusive. This study aims to investigate postoperative weight changes and their impact on functional scores following knee and hip arthroplasty, exploring factors influencing these changes.
METHODS A total of 459 knee and hip arthroplasty cases with a 2-year follow-up were analyzed. BMI and Oxford scores were tracked, alongside factors including comorbidities, corticosteroid use, physiotherapy, and unilateral vs. bilateral surgery.
EXPECTED OUTCOMES Based on the study's design and the data available, we anticipate observing the impact of changes in patients' BMI on clinical scores as an independent variable. Additionally, we aim to elucidate the effects of comorbidities, corticosteroid use, physiatrist follow-up, and the type of surgical procedure on both BMI and clinical outcomes. Through this analysis, we expect to gain a comprehensive understanding of how these factors interplay to influence postoperative recovery and overall patient health.
- Conditions
- Arthropathy, Obesity
- Being tested
- Total Knee Arthroplasty, Total Hip arthroplasty
- Keywords
- Total Hip Arthroplasty, Total Knee Arthroplasty, Weight Loss, Obesity, Body Mass Index
- Medical subject headings
- Joint Diseases, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Patients undergoing total knee arthroplasty
Total Hip arthroplastyProcedure or surgery
Patients undergoing total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Arthroplasty | Active comparator | Patients indicated for total knee arthroplasty. Receives: Procedure: Total Knee Arthroplasty |
| Total Hip Arthroplasty | Active comparator | Patients indicated for total hip arthroplasty. Receives: Procedure: Total Hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Measured: 2 years
Oxford hip and knee scores
It is scored between 0 and 48. 48 is the best function.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jan 2018
- Primary completion30 Dec 2022
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mete Ozer, Istanbul University - Cerrahpasa
- Investigators
- Cumhur Deniz Davulcu, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440863
- Sponsor's protocol ID
- Y7MQG7gO
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes All demographic data, clinical scores, and BMI measurement results will be shared.
Publications
Woodruff MJ, Stone MH. Comparison of weight changes after total hip or knee arthroplasty. J Arthroplasty. 2001 Jan;16(1):22-4. doi: 10.1054/arth.2001.9826.
PubMed 11172266Riddle DL, Singh JA, Harmsen WS, Schleck CD, Lewallen DG. Clinically important body weight gain following knee arthroplasty: a five-year comparative cohort study. Arthritis Care Res (Hoboken). 2013 May;65(5):669-77. doi: 10.1002/acr.21880.
PubMed 23203539Inacio MC, Silverstein DK, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian D. Weight patterns before and after total joint arthroplasty and characteristics associated with weight change. Perm J. 2014 Winter;18(1):25-31. doi: 10.7812/TPP/13-082.
PubMed 24626069
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Changes in Body Mass Index After Total Knee and Hip Arthroplasty on Patient Functional Scores
- ClinicalTrials.gov ID
- NCT06440863
- Acronym / sponsor ID
- Y7MQG7gO
- Conditions
- Arthropathy, Obesity
- Keywords
- Total Hip Arthroplasty, Total Knee Arthroplasty, Weight Loss, Obesity, Body Mass Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PURPOSE Obesity poses challenges to preoperative mobility and functional recovery for arthroplasty patients, yet postoperative weight loss remains elusive. This study aims to investigate postoperative weight changes and their impact on functional scores following knee and hip arthroplasty, exploring factors influencing these changes.
METHODS A total of 459 knee and hip arthroplasty cases with a 2-year follow-up were analyzed. BMI and Oxford scores were tracked, alongside factors including comorbidities, corticosteroid use, physiotherapy, and unilateral vs. bilateral surgery.
EXPECTED OUTCOMES Based on the study's design and the data available, we anticipate observing the impact of changes in patients' BMI on clinical scores as an independent variable. Additionally, we aim to elucidate the effects of comorbidities, corticosteroid use, physiatrist follow-up, and the type of surgical procedure on both BMI and clinical outcomes. Through this analysis, we expect to gain a comprehensive understanding of how these factors interplay to influence postoperative recovery and overall patient health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arthroplasty | Active comparator | Procedure: Total Knee ArthroplastyPatients indicated for total knee arthroplasty. |
| Total Hip Arthroplasty | Active comparator | Procedure: Total Hip arthroplastyPatients indicated for total hip arthroplasty. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent primary TKA and THA with a 2-year follow-up were included
Key exclusion criteria (3 listed)
- Patients who underwent bariatric surgery before or after the surgery
- Incomplete 2-year follow-up
- Whom BMI or Oxford scores could not be accessed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee ArthroplastyPatients undergoing total knee arthroplasty | Procedure or surgery | Total Knee Arthroplasty |
| Total Hip arthroplastyPatients undergoing total hip arthroplasty | Procedure or surgery | Total Hip Arthroplasty |
Primary outcome
BMI
Time frame: 2 years
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Oxford hip and knee scores
Time frame: 2 years
It is scored between 0 and 48. 48 is the best function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 11172266Woodruff MJ, Stone MH. Comparison of weight changes after total hip or knee arthroplasty. J Arthroplasty. 2001 Jan;16(1):22-4. doi: 10.1054/arth.2001.9826.
- Background: PubMed 23203539Riddle DL, Singh JA, Harmsen WS, Schleck CD, Lewallen DG. Clinically important body weight gain following knee arthroplasty: a five-year comparative cohort study. Arthritis Care Res (Hoboken). 2013 May;65(5):669-77. doi: 10.1002/acr.21880.
- Background: PubMed 24626069Inacio MC, Silverstein DK, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian D. Weight patterns before and after total joint arthroplasty and characteristics associated with weight change. Perm J. 2014 Winter;18(1):25-31. doi: 10.7812/TPP/13-082.
- Individual participant dataSharing planned: Yes. Yes All demographic data, clinical scores, and BMI measurement results will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cumhur Deniz Davulcu principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Arthroplasty and Total Hip arthroplasty in people with Arthropathy and Obesity, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06440863, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024; AzTrials last refreshed its copy on 30 Oct 2026.